G-CSF for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03793205|
Recruitment Status : Unknown
Verified January 2019 by Lei Li, Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : January 4, 2019
Last Update Posted : January 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gynecologic Cancer Myelosuppression Adult Febrile Neutropenia Chemotherapy-induced Neutropenia||Drug: Long-acting G-CSF Drug: Short-acting G-CSF||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||After the chemotherapy, patients accepted long-acting G-CSF and/or short-acting G-CSF.|
|Masking:||None (Open Label)|
|Official Title:||Long-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Gynecologic Cancer Patients: A Prospective Cohort Study|
|Actual Study Start Date :||January 3, 2019|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||January 1, 2020|
Experimental: Long-acting G-CSF group
Patients in long-acting G-CSF group accept long-acting with or without short-acting G-CSF.
Drug: Long-acting G-CSF
Long-acting G-CSF will be given 48 hours after the chemotherapy. A supplement of short-acting G-CSF will be given as required.
Experimental: Short-acting G-CSF group
Patients in long-acting G-CSF group only accept short-acting G-CSF.
Drug: Short-acting G-CSF
Short-acting G-CSF will be given as required 24 hours after the chemotherapy.
- Incidence of febrile neutropenia [ Time Frame: One year ]Incidence of febrile neutropenia in each course
- Incidences of grade 3/4 myelosuppression [ Time Frame: One year ]Incidences of grade 3/4 myelosuppression in each course
- Times of visits to outpatient and emergency clinics [ Time Frame: One year ]Visits to outpatient and emergency clinics in each course
- Doses of G-CSF [ Time Frame: One year ]Doses of G-CSF administrated in each course
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793205
|Contact: Lei Lifirstname.lastname@example.org|
|Beijing, Beijing, China, 100730|
|Contact: Lei Li, MD 008613911988831 email@example.com|